Cleared Traditional

K093639 - SLIT LAMP

K093639 is an FDA 510(k) clearance for SLIT LAMP, manufactured by Huvitz Co., Ltd.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K093639 · Huvitz Co., Ltd. · Ophthalmic device
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Dec 2009
Decision
9d
Days
Class 2
Risk

K093639 is an FDA 510(k) clearance for the SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Huvitz Co., Ltd. (Tempe, US). The FDA issued a Cleared decision on December 3, 2009 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Huvitz Co., Ltd. devices

FDA 510(k) Submission Details - K093639

510(k) Number K093639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2009
Decision Date December 03, 2009
Days to Decision 9 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 110d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HJO Biomicroscope, Slit-lamp, Ac-powered

All 31
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K093639.
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